Medical Journal Piece Suggests Solutions to Generic Labeling Quandary

Published Online: Friday, December 14, 2012

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As legal requirements surround generic drug labels and liability for adverse reactions remains under debate, physicians from Harvard Medical School and Brigham and Women’s Hospital contend that the current proposals would compromise the generics industry.

In a perspective piece appearing in the November 1, 2012, edition of The New England Journal of Medicine, Aaron S. Kesselheim, MD, JD, MPH, Jerry Avorn, MD, and Jeremiah A. Green, MD, PhD, suggest that proposals to increase liability for generics manufacturers would not solve problems that arise when patients experience adverse affects after a brandname drug or generic equivalent is already on the market.

A 2011 Supreme Court case determined that generic manufacturers are not responsible for updates to product labels. The ruling prompted representatives from Maryland and Vermont to introduce House and Senate amendments allowing manufacturers to revise generic labels to cover additional warnings or updates on marketed products without the FDA’s approval.

The proposed measures ignore generic manufacturers’ position in the pharmaceutical market, the authors stated. They noted that the small size of many generic companies inhibits the surveillance measures suggested in the amendment. In turn, the measures may not generate sufficient information on adverse drug reactions while also affecting the price of generic equivalents. Instead, the authors recommend an FDA-based information source for studying after-market side effects and for recommending drug label changes. The FDA Sentinel Initiative, which monitors drugs, biologics, and medical devices after market, or the Patient-Centered Outcomes Research Institute would be suited to the task, the authors stated. The authors also recommended a nominal fee system to cover database costs, to remove manufacturer funding of drug risk research.

The approach could also be used to fund compensation for injuries sustained after a brand-name drug loses exclusivity, similar to the vaccination injury system created in the 1980s. Under that system, patients injured by vaccines are compensated from a fund supported by federal fees on each vaccine dose administered. Under the authors’ systems, generic manufacturers would only be liable if their product label did not match.